Mon Mar 03 02:35:50 UTC 2025: ## Glenmark Recalls Nearly 1.5 Million ADHD Medication Bottles in US
**New Delhi, March 3, 2025** – Glenmark Pharmaceuticals is recalling approximately 1.47 million bottles of its Atomoxetine capsules in the United States due to unacceptable levels of an impurity, according to the U.S. Food and Drug Administration (USFDA). The recall, initiated on January 29th, affects multiple strengths of the generic ADHD medication manufactured in India by a subsidiary of the Mumbai-based company.
The USFDA classified the recall as Class II, meaning that use of the affected product could cause temporary or reversible adverse health consequences, although the risk of serious harm is considered low. The impurity, N-Nitroso Atomoxetine, exceeds the FDA’s recommended limit. The recall covers capsules ranging from 10mg to 100mg. The USFDA Enforcement Report cites “CGMP Deviations” as the reason for the recall.
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder affecting children and adults, impacting focus, impulse control, and activity levels.
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